A Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally in Healthy Participants

Launched by LATIGO BIOTHERAPEUTICS · Sep 15, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new medication called LTG-001, which is taken by mouth. The main goal is to see if this medication is safe and how the body processes it in healthy adults. The study will involve giving participants different doses of the medication to find out the best and safest amount to use. It is a Phase 1 trial, meaning it is one of the first steps in testing a new drug in people.

To participate, you need to be between 18 and 55 years old and in good health, with no serious medical conditions. Participants should not have any issues that could affect their ability to take the medication or participate fully in the study. If you join, you can expect to be closely monitored by medical professionals, and you will receive either the medication or a placebo (a dummy pill that looks like the real one but has no active ingredients) during the study. This trial is currently recruiting, so it offers a chance to be part of the early research for a potentially new treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male and female participants aged 18 to 55 years, inclusive, at the time of signing the informed consent.
• • Overtly healthy with no clinically relevant abnormalities based on the medical history, physical examinations, clinical laboratory evaluations, and 12-lead ECG that, in the opinion of the investigator, would affect participant safety.
• • Body mass index (BMI) within the range of 18-32 kg/m2 (inclusive).
• Exclusion Criteria:
• • Inability to take oral medications or gastrointestinal abnormalities potentially impacting absorption
• • Clinically significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the investigator, unacceptably increase the participant's risk by participating in the study
• • Past or current history or evidence of alcohol abuse and/or dependence on recreational drug use
• • Donation of over 500 mL blood ≤ 3 months prior to start of participation
• • Has known psychiatric disorders that would interfere with the cooperation with the requirements of the study
• • Participant is under legal custodianship.